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Exception to Informed Consent | Overview

What is Exception from Informed Consent (EFIC)?

The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research protection involving medicines. The FDA has created a set of special rules, called “Exception from Informed Consent” (EFIC), for clinical trials that apply to critically ill patients who require emergent therapy when prospective informed consent is not possible or may put the patient at risk for increased harm by delaying potentially life-saving therapies.

Under some circumstances, there may not be time to seek informed consent ahead of time from every eligible patient and, in some cases, discussing a possible option to enroll in a study may itself cause dangerous delays in a person’s care. Nonetheless, many critically ill patients could benefit from enrollment into an appropriate clinical trial. Therefore, to ensure that clinical trials can be conducted for patients in emergency situations, the FDA established rules for EFIC that require special safeguards to ensure that most people would consider the study to be ethical and appropriate. These special rules allow research studies in certain emergency situations to be conducted without prospective informed consent.

EFIC can only be used when:

  • the person’s life is at risk
  • AND the best treatment is not known
  • AND the study might help the person
  • AND it is not possible to get permission ahead of time:
    • from the person because of his or her medical condition
    • nor from the person’s guardian because there is a very short amount of time required to treat the medical problem

Before researchers can start a study using EFIC, they must provide information about the study to the community and get their feedback. We will be conducting focus groups and getting feedback about the study online from Boston Children’s families. If you would like to fill out a short online survey, visit this webpage.